Material Characterization Screens of Raw Materials

Nelson Labs offers a comprehensive set of tests for characterization and screening of raw materials. Material screening helps manufacturers select their suppliers, and with routine monitoring of materials ensures delivery of a consistent product. Some screening tests are qualitative, providing information related to compound identity only, while others are qualitative in nature.

Manufacturers must evaluate potential raw materials to determine whether they are of sufficient quality to meet the goals of the device and be released into production. Material evaluation can be accomplished through review of information provided by the supplier in technical documentation like a certificate of analysis (COA), or in cases where supplied information is not sufficiently detailed, testing may need to be performed to ensure material quality meets the needed specifications.

For medical device manufacturers, tests on incoming materials may include bioburden, chemichal composition (to ensure the material is free from CMRs), or physical-chemical properties of a material to ensure incoming materials are unlikely to cause biocompatibility problems later or to check consistency lot to lot. Below is a summary of tests available to screen materials applicable to medical device manufacturers.

For pharmaceutical manufacturers, additional tests may include screening active pharmaceutical ingredients (APIs) for potency, purity, and impurities; chemical analyses of pharmaceutical containers and stoppers using extractables and leachables (E&L) testing and analysis of raw materials used in pharmaceutical production (e.g., water sources).

Testing Locations

Study Outline

Differential Scanning Calorimetry (DSC)

The Differential Scanning Calorimetry (DSC) determines intrinsic properties of polymers related to phase changes such as crystallization temperature, glass transition temperatures, and melting point. Because the temperatures associated with phase changes are intimately related to a material’s chemical formulation and internal structure, this test can be used to compare materials lot to lot to screen for differences.

The testing which is recommended in ISO 10993-12 and ISO 10993-18 meets the criteria set fourth in USP General Chapter 32 and the National Formulary 27, 891.

Fourier Transfer Infrared (FTIR) Spectroscopy

FTIR spectroscopy measures molecular vibrations of organic molecular vibrations of organic molecules in a probed substance or material. Because the set of molecular vibrations of a material relates directly to the material formulation, this method is excellent at comparing materials in hand (or those that have been measured previously) to determine if they are the same. For example, FTIR can be used to determine if a sterilization process harms a material by comparing the spectra of the material before and after the process. For pure chemicals or materials, FTIR can assist in the identification of the substance, for unknown mixtures like non-volatile residuals FTIR is of limited utility. FTIR is most often used to compare material from lot to lot, before and after a processing step to check for equivalency, or to aid in the identification of particulate contamination on a product. Materials tested include polymers, finished products, oil lubricants, and other organic material.

This testing which is recommended in ISO 10993-12 and ISO 10993-13 is performed according to criteria outlined in USP General Chapter 32 and the National Formulary 27, 2009, Chapter 851.

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